Package for surgical sutures



Feb. 25, 1958 J.'A. STOLTZ 2,824,642

PACKAGE FOR SURGICAL SUTURES Filed July 5, 195a INVENTOR. JAMES A. ST L TZ A T TORA/EY United States atent 2,824,642 getented Feb. 25', 1958 This invention relates to a package forsurgical sutures and: more particularly to a package which facilitates: and

expedites. the delivery of .such. sutures. in sterile condition to, a sterile .area as. by spilling 'orwas by removing;v with sterile. forceps or fingers alone.

Itiss-aprimaryobject of the invention to 'providewa surgical suture package which is compact, economical oi-lrnanufacture, and which assures maximum safetyin dehveringthesuture in sterile conditions to the site ofzthe operative field-r More specifically, it is an object of the present invention. toprovide such a package wherein extremely wide marginal safety factors v.-are provided for such: steriledclivery and ease of usage not previouslyavailable.

,Ano-therobject of. the invention is toprovide azsterile suture pack whereby the'characterand-type of sutureis easily identifiable by operating room personnel at alltimes. A.salient: .feature of thepresent invention: lies. in its easy accommodation to conventional operating roorrrprocedures, and inthe fact that the sterile nurse mayzdeliver thesutureto the'operating surgeon with assurance of Tabsolutexsterility. V v

general, the present. invention contemplates packaging the suture-within a label which completeiyenfolds the suture, packaging the suture containing label; within an. inner telescoping type .envelope, and,.lastly, packaging the inner. telescoping type: of envelope withinan'zouter envelopewith the label, inner envelope, and'.outer:envelope each marginally over-extending each other: and the perimiter ofthe'coiled suture material. 7

Another aspect of the invention lies in the provisions-of outwardly flared. lips on the: ends of the enfoldeddabel stock which encases the suture, which lips serve to facilitate the opening .of the opposed flaps for spilling .the suture upona sterile area, as well as (if preferred) facilitating the easy ingressof forcep tips for removingethe suture in a sterile condition and passingthesame'totthe operating, surgeon.

Another aspect of this invention ;is that a suture.nurse or. other sterile person can. remove the; entire inner::telescoping envelopezfrom theouter package while his held by. acirculating-nurse-without. any danger of.contamination..

I .The inner package: affords anease-ofjhandlingxbygeither the. suture. nurse or the. circulating nurse with. an ease hitherto unavailable with; glasswtubes; or: packages.:previou sly used, andithis is-so because of .their inflexibility. It. is. .;not necessary; that the present invention .to: spillthe package overithersterileffield; however, this may .'be. done if so desired. I

These: and otherv objects of. this invention. will become apparcnt.:.to:those-; skilled. in;.the arttuporr becoming familiar. witmthefollowing. descriptionwhen'takenv in .conjunction- .with the: accompanying; drawing in; which. like parts aredesigpatedby, like numerals andinwhich:

Fig; 1 is.;a,perspective: view ofzrny improved. sterile,

surgical, suture. pack-..and. diagrammatically illustrates-the 1 removal of one end of the outer envelope,

Fig.2 is an enlarged longitudinal sectional elevation thereof,

Fig.3 is a..transverse, cross-sectional elevation-in reduced scale, of. the outer fiat tubular envelope,

Fig. 4 is an; exploded perspective view. illustrating the top and .bottom parts of the inner envelope and the coiled suture enfoldedwithin the indicia-bearing label, and

Fig-5'is..a.perspective view showing thebase of the inner,: telescoping envelope and the suture enfolding label with forcep tips poised for easy ingress to insure sterile removal Ofthesterile suture.

Referring .to Fig. 1, the completed packagecomprises an outer.envelope.10 preferably formed of flat, transparent, gas-, heat.-, or electron-permeable, plastic material; an inner envelope consisting of a top -11 telescopically sliding with arelatively close tolerant fit over a base envelope.l2jandspreferably. of. such length as to substantiallycornpletely: sheath. the latter; The plastic material may berpolyethylene, .Mylar, Kell-F, or like material; Within base :cnvelope 12 is an enfolded strip of relatively thin .but'rigid. paperstock label 13 creased at 14 to.formnashingehline providing two opposed flaps 15 and 16. The suture material 17 is coiled as clearly shown in Figs'.,2 311(1141. Theperimeter-of the coil of: suture -material,ispreferably;of:suchdimension that. it lies well within. the confinesmar-ginally ofthe side edges and ends of flaps sl5iandr16. Theinner portion 17a of the outer convolution. ofccoili' 17 lrests-adj'acent to .the hinged line 14and. its. outer portion 18 lies within the plane indicated by dot-and-dash' line 19; as shown in Fig. 4, so that the outer ends of the flaps 15; and 16. over-extend with a-considerable margin. as a safety factor the perimeter of said opposedconvolution." The outer flaps-may be'tapered along their opposite edges commencing from line 19', in-

wardly towardtheir outer ends as illustrated in. Figs.-- 1,

4,. and5. The. extreme outer ends of said flaps desirably terminatein outwardly flared lips 20 and 21, respectively, for a. purpose later to be described. These lips maybe formed. as by scoring the paperboard stock a short distance inwardly from their outer ends as indicated in'Fig. 2 at 22 and 23, respectively.

The suture 17 enfolded within flaps 15'and16, asdescribed, is nextinserted within the bottom or base 12'0f the innertelescoping envelope 11'12.

taining thesuture 17,.which, in turn, is marginally encased therewithin as previously described... I Following this, the assembled'inner envelope 11'12 .is slid withintheconfines of aflat, tubular, transparent outer envelope 10 (shown increduced scale. in Fig. 3). The. opposed: ends of .said envelope, .at the timer-of insertion, are open. Following'insertion .of'the inner-envelope the ends of outer envelope'lti are thermosealedas at 25. ltisrto'be noted herethat. theaouterg envelope is preferablyof such dimension as torrnarginally-overextend perimetrically the o'uteredges and ends of'the innerenvelope 11,-12, Withsuch an excess of margin at all edgesgand ends as will permit of an, easy",.casual clipping ofl of one end of. said outer envelope 1.0 or one end. and. one adjoining side, edgeof said envelope topallow the. removal of the inner, envelopefromwithin .the-outerone. t

t The, completed, thermosealed. package; may then; be placed within a suitable sterilizing chamber, such as an autoclave, or the like; preferably it is placed within a chamber containing carboxide gas under sufficient pressure to completely permeate the walls of outer envelope 10, the walls of inner envelope 11-12, the paperstock label 13, and the suture material per se 17. The completed package is left in such sterilizing chamber for a suificient period of time commensurate with the particular type of sterilizing agent used (dry heat, gas, vapor, or electron beam) to ensure complete sterility of each and all of the component parts of the package as described.

In operation, this package may be opened by the circulating nurse in the following manner: surgical scissors, such as are indicated at 26, are manipulated to clip one end of outer envelope 10 just inwardly of the thermoseal 25. It is here noted that even though scissors 26 be sterile if, perchance, the exterior of outer envelope 10 has, for any reason, become unsterile, the contamination of the edges of outer envelope 10 can in no manner be communicated to inner envelope 11-12, or label 13, or suture 17 due to their progressively, respective, larger marginal encasements. Following the clipping off of either end or one end and one side edge of outer envelope 10, inner package 11-12 is removed from such open end and/or side. Next, holding the base 12, preferably as illustrated in Fig. 5, the telescoping top 11 is slid upwardly therefrom, exposing the tapered, projecting ends of flaps 15-16.

At this point, the removal of suture 17 in sterile conditionmay take either of three optional forms of procedure: first, with some marked degree of safety and casualness, the sterile'nurse may grasp lips 20-21, invert label 13, and pull flaps 15-16 apart about hinge line 14, to permit sterile suture 17 to spill upon a sterile area; secondly, by simply folding back the two free corners of the outside package (this only in the event two adjoining edges of outer envelope 10 are cut by circulating nurse) the sterile nurse can remove with her fingers the entire inner pack 11-12; thirdly, if desired, the tips 27 (Fig. of surgical forceps may be easily and expeditiously slid between guiding lips 20-21 of flaps 15-16 into a firm and positive engagement with suture 17 for its safe, aseptic withdrawal, either when one end edge of outer envelope is cut or when two adjoining edges (one end edge and one adjoining side edge) are cut. So long as the tips 27 of the surgical forceps are sterile, or so long as the finger tips of the circulating nurse engage only the outwardly flared lips 20-21 of flaps -16 the possibility of rendering suture 17 unsterile during removal is rendered nil. Moreover, due to the progressively increasing marginal extensions of flaps 15-16, top and base inner envelope 11-12, and outer envelope 10, the opportunity of contaminating suture material 17, which, in effect, is in a sterile sanctum sanctorum, is reduced to substantially an impossibility. Notwithstanding this, the removal procedures may be carried on in a rather casual manner. In other words, with only slight care, an unsterile or circulating nurse or surgical or sterile, operating assistant can deliver suture 17, irrespective of their sterile or unsterile status, to the operating surgeon either by sterile gloved hand, or by spilling, or by passage with forceps in a safe, aseptic, and facile manner.

It is to be noted here that the transparency of outer envelope 10 and inner envelope 11-12, respectively, permits easy identification of the type and character of the suture by simply reading the indicia imprinted upon the opposed outer faces of flaps 15-16 of label 13.

While the invention has been described in conjunction with sutures, it will be understood that it can be applied to other forms of material which necessitate sterile pack aging for operating room use.

Although the invention has been described with reference to certain particular embodiments, it is to be understood that it is not limited thereby; therefore, changes,

omissions, substitutions, and/ or additions may be made without departing from the spirit of the invention as defined in the appended claims.

I claim:

1. A sterile surgical suture package comprising a coiled suture; a label having a pair of oppositely disposed, hinged-together flaps; the inner portion of the periphery of said coiled suture lying immediately adjacent the hinge of and between said flaps and the outer portion of the periphery of said coil lying in a plane substantially inwardly from the free ends of said flaps, the width and length of said flaps completely overextending marginally said periphery; said suture so marginally encased between said label being further marginally encased within an inner, telescoping, two-piece, top and base type of envelope of sterilizing agent-permeable, transparent, plastic material; the outer edge of said base lying substantially flush with the plane of the outer periphery of said coiled suture; said ends of said fiaps projecting beyond said outer edge of said base of said inner envelope and being completely encased by said top thereof; said inner envelope being encased within an outer one-piece, fiat, tubular, envelope of sterilizing agent-permeable, transparent, plastic material; the opposed sides and ends of said outer envelope being spaced marginally from the corresponding sides and ends of said inner envelope and the opposed ends of said outer envelope being thermosealed; and the complete package being subjected to sterilization in a chamber wherein sterilizing agents capable of permeating the outer envelope, the inner envelope, the label, and the suture do permeate all of said elements and render them sterile; whereby one or a pair of adjoining edges of said outer envelope may be cut to facilitate the casual but assuredly sterile removal of the inner envelope and its suture therefrom by either a spilling or forcep technique.

2. A sterile surgical suture package comprising a coiled suture; a label having a pair of oppositely disposed,

hinged-together flaps; indicia designating the character and size of a coiled suture imprinted on at least one of the opposed outer faces of said flaps; the inner portion of the periphery of said coiled suture lying immediately adjacent the hinge of and between said flaps and the outer portion of the periphery of said coil lying in a plane substantially inwardly from the free ends of said flaps, the width and length of said flaps completely overextending marginally said periphery; said free ends of said flaps being flared outwardly along a transverse score line to provide lips for facilitating easy ingress guidance for forceps or grasping finger tips remote from the suture coil; said suture so marginally encased between said label being further marginally encased within an inner, telescoping, two-piece top and base type of envelope of sterilizing agent-permeable, transparent, plastic material;

the outer edge of said base lying substantially flush with the plane of the outer periphery of said coiled suture; said ends of said flaps projecting beyond said outer edge of said base of said inner envelope and being completely encased by said top thereof; said inner envelope being encased within an outer one-piece, fiat, tubular, envelope of sterilizing agent-permeable, transparent, plastic material; the opposed sides and ends of said outer envelope being spaced marginally from the corresponding sides and ends of said inner envelope and the opposed ends I of said outer envelope being thermosealed; and the com- 65 plete package being subjected to sterilization in a chamber wherein sterilizing agents capable .of permeating the outer envelope, the inner envelope, the label, and the suture do permeate all of said elements and render them sterile; whereby one or a pair of adjoining edges of said outer envelope may be cut to facilitate the casual but assuredly sterileremoval of the inner envelope and its suture therefrom by either a spilling or forcep technique.

7 3. A sterile surgical suture package comprising a coiled suture; a label having a pair of oppositely disposed,

hinged-together flaps; indicia designating the character and size of a coiled suture imprinted on at least one of the opposed outer faces of said flaps; the inner portion of the periphery of said coiled suture lying immediately adjacent the hinge of and between said flaps and the outer portion of the periphery of said coil lying in a plane substantially inwardly from the free ends of such flaps, the width and length of said flaps completely overextending marginally said periphery; said free ends of said flaps being tapered along their side edges and flared outwardly along a transverse score line to provide lips for facilitaing easy ingress guidance for forceps or grasping finger tips remote from the suture coil; said suture so marginally encased between said label being further marginally encased within an inner, telescoping, two-piece top and base type of envelope of sterilizing agent-permeable, transparent, plastic material; the outer edge of said base lying substantially flush with the plane of the outer periphery of said coiled suture; said tapered ends of said flaps projecting beyond said outer edge of said base of said inner envelope and being encased completely 20 by said top thereof; said inner envelope being encased within an outer one-piece, flat, tubular, envelope of sterilizing agent-permeable, transparent, plastic material; the

opposed sides and ends of said outer' envelope being spaced marginally from the corresponding sides and ends of said inner envelope and the opposed ends of said outer envelope being thermosealed; and the complete package being subjected to sterilization in a chamber wherein sterilizing agents capable of permeating the outer envelope, the inner envelope, the label, and the suture do permeate all of said elements and render them sterile; whereby one or a pair of adjoining edges of said outer envelope may be cut to facilitate the casual but assuredly sterile removal of the inner envelope and its suture therefrom by either a spilling or forcep technique.

References Cited in the file of this patent UNITED STATES PATENTS 1,962,900 Hirsch June 12, 1934 2,542,957 Adams Feb. 20, 1951 FOREIGN PATENTS 646,743 Great Britain Nov. 29, 1950 647,566 Great Britain Dec. 13, 1950 747,162 Great Britain Mar. 28, 1956 

